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Validation of a sensitive LC-MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: an OPRU Network study.
- Source :
-
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences [J Chromatogr B Analyt Technol Biomed Life Sci] 2007 Dec 01; Vol. 860 (1), pp. 34-41. Date of Electronic Publication: 2007 Oct 22. - Publication Year :
- 2007
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Abstract
- Glyburide (glibenclamide, INN), a second generation sulfonylurea is widely used in the treatment of gestational diabetes mellitus (GDM). None of the previously reported analytical methods provide adequate sensitivity for the expected sub-nanogram/mL maternal and umbilical cord plasma concentrations of glyburide during pregnancy. We developed and validated a sensitive and low sample volume liquid chromatographic-mass spectrometric (LC-MS) method for simultaneous determination of glyburide (GLY) and its metabolite, 4-transhydroxy glyburide (M1) in human plasma (0.5 mL) or urine (0.1 mL). The limits of quantitation (LOQ) for GLY and M1 in plasma were 0.25 and 0.40 ng/mL, respectively whereas it was 1.06 ng/mL for M1 in urine. As measured by quality control samples, precision (% coefficient of variation) of the assay was <15% whereas the accuracy (% deviation from expected) ranged from -10.1 to 14.3%. We found that the GLY metabolite, M1 is excreted in the urine as the glucuronide-conjugate.
- Subjects :
- Diabetes, Gestational blood
Diabetes, Gestational urine
Female
Glucuronidase metabolism
Glyburide metabolism
Humans
Pregnancy
Reproducibility of Results
Sensitivity and Specificity
Chromatography, High Pressure Liquid methods
Glyburide analogs & derivatives
Glyburide blood
Glyburide urine
Mass Spectrometry methods
Subjects
Details
- Language :
- English
- ISSN :
- 1570-0232
- Volume :
- 860
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
- Publication Type :
- Academic Journal
- Accession number :
- 17980680
- Full Text :
- https://doi.org/10.1016/j.jchromb.2007.10.010